Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01486888
NCT01486888
Completed
Phase 1

A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulin Mixtard® 30 (600 Nmol/ml) and Insulin Mixtard® 30 (1998 Nmol/ml) in Healthy Subjects

Novo Nordisk A/S0 sites45 target enrollmentMay 2006
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsDiabetesHealthy
Interventionsbiphasic human insulin 30
Drugsbiphasic human insulin 30

Overview

Phase
Phase 1
Intervention
biphasic human insulin 30
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
45
Primary Endpoint
Maximum serum insulin concentration (Cmax)
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence between two formulations of Mixtard® 30 in healthy subjects.

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
July 2006
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
  • •Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive
  • •Non-smoker, defined as no nicotine consumption for at least one year
  • •Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria

  • •Previous participation in this trial or other clinical trials within the last 3 months
  • •Body weight above 87.5 kg
  • •Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3
  • •History of alcohol or drug abuse

Arms & Interventions

Formulation A

Intervention: biphasic human insulin 30

Formulation B

Intervention: biphasic human insulin 30

Outcomes

Primary Outcomes

Maximum serum insulin concentration (Cmax)

Area under the serum insulin concentration-time curve (AUC 0-24 hours)

Secondary Outcomes

  • Area under the serum insulin concentration-time curve (AUC 6-24 hours)
  • Area under the serum insulin concentration-time curve (AUC 0-6 hours)
  • Terminal insulin half life (t½)
  • Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)
  • Time to maximum serum insulin concentration (tmax)
  • Adverse events

Similar Trials

Completed
Phase 1
Bioequivalence of Two Insulatard® Formulations in Healthy SubjectsDiabetesHealthy
NCT01486901Novo Nordisk A/S44
Completed
Phase 1
Bioequivalence Between Two Explorative Insulin Degludec Formulations and Between Two Explorative IDegAsp Formulations in Healthy SubjectsDiabetesHealthy
NCT01868581Novo Nordisk A/S58
Completed
Phase 1
Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)DiabetesHealthy
NCT01530048Novo Nordisk A/S34
Completed
Phase 1
Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy SubjectsDiabetesHealthy
NCT01490099Novo Nordisk A/S37
Completed
Phase 1
A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing ProcessesDiabetesHealthy
NCT01766245Novo Nordisk A/S28